Ross Marchand, executive director of the Taxpayers Protection Alliance, said federal regulators are increasingly delaying patient access to treatments as drug rejection rates rise, during an interview on the Health Policy Podcast, according to Atlas Point Media News Staff.
Marchand cited findings from a report titled Blocking Breakthroughs, which analyzed trends in U.S. Food and Drug Administration approvals over the past decade. "We found that over the past 10 years, rejection rates for medications has been going up and the cost of the FDA evaluating these treatments… is also going up," Marchand said. The report examined both aggregate data and individual case studies, identifying repeated delays tied to regulatory reviews, shifting requirements, and additional data requests during the approval process.
Marchand said some medications approved in countries including the United Kingdom, European Union, and Switzerland have faced extended review timelines in the United States. "They’ll say… there are manufacturing deficiencies… and then the company goes back… and then the FDA says… we identified another issue," Marchand said, describing a pattern of changing requirements. He said the approval process can take years for certain treatments, including medications targeting rare diseases where patient populations are limited and clinical trial data may rely on historical comparisons.
Marchand also said the cost of bringing a drug to market is approximately $2 billion, driven by clinical trials and regulatory compliance requirements. In addition to delays in new drug approvals, he said some widely used medications remain restricted to prescription use despite broader availability in other countries. "Statins… should absolutely be over the counter," he said, noting these medications are available without a prescription in the United Kingdom.
Marchand said regulatory policy changes could improve access by recognizing approvals from international regulators, allowing provisional approvals for certain medications, and expanding over-the-counter availability for drugs with established safety profiles. The discussion focused on how regulatory decisions affect patient access to treatments, drug development costs, and pharmaceutical innovation in the United States.
More information about this interview can be found at the organization's website.
